(67 days)
Jelenko Albacast
Not Found
No
The summary describes a dental casting alloy and its physical properties, with no mention of software, image processing, or AI/ML terms.
No.
Explanation: The device is a dental casting alloy used for making restorations, which is a material rather than a therapeutic device designed to treat or alleviate a disease or condition.
No
The device is a dental casting alloy used for making restorations, not for diagnosing medical conditions. The "Intended Use" clearly states its purpose is for "making restoration," which is a treatment or repair, not a diagnostic procedure.
No
The device description clearly states it is a "Silver-palladium based casting alloy," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Dental casting alloy for making restoration." This describes a material used to create physical dental prosthetics, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: It's a "Silver-palladium based casting alloy," which is a material used in manufacturing.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental casting alloy does not fit that description.
N/A
Intended Use / Indications for Use
Dental casting alloy for making restoration. (NOT FOR USE WITH DENTAL PORCELAIN )
Product codes
EJT
Device Description
Silver-palladium based casting alloy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Jelenko Albacast
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
AUG 26 1997
Image /page/0/Picture/2 description: The image shows a logo with two overlapping triangles and the word "AUREX" underneath. The triangles are black and appear to be slightly rounded at the corners. The word "AUREX" is in a simple, sans-serif font and is also black.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone:+27 (11) 609-8640 Telefax : +27 (11) 452-3918
510 (k) Summary
Trade name: AURECAST GF Dental casting alloy Common name: Gold based alloys and precious metal alloys for clinical use Classification name: EJT Class ification number:
Legally marketed device: Jelenko Albacast Description of the device: Silver-palladium based casting alloy Intended use of the device: Type III restorations
Summary of the technological characteristics Test methods applied: as in ANSI/ADA 5
Comparison of composition:
- 1 -
| ALLOY | COMPOSITION (weight%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Name | Ag | Pd | Cu | Zn | In | Ru | Ir | |
| Legal | Albacast | 70 | 25 | 0 | 2 | 3 | 0 | x |
| New | AurecastGF | 72.1 | 24 | 0.2 | 1 | 2.5 | 0.2 | 0.3 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | | Melting point range (°C) | | Hardness
(Vickers 5/30) | | Yield strength
(MPa) | | Elongation
(%) | | Density
(g/cm3) |
|-------|------------|--------------------------|--------|----------------------------|------|-------------------------|------|-------------------|------|--------------------|
| | Name | solid | liquid | soft | hard | soft | hard | soft | hard | |
| Legal | Albacast | 1020 | 1100 | 158 | 162 | 300 | 350 | 14 | 10 | 10.6 |
| New | AurecastGF | 1100 | 1115 | 130 | 155 | 330 | 350 | 18 | 13 | 10.6 |
Discussion
The constituents above 1% are the same. The concentration difference in the major component (silver) is less than 3 %. The base metal content is slightly less in the new alloy.
Conclusion
The mechanical properties of the two alloys are very similar, and considering the constitutions it may be assumed that also the chemical properties and biological effect should be very similar.
Procious Motal Industries (Ptv) Limited (Reg.No. 88/04891/07)
Image /page/0/Figure/18 description: The image shows a logo with the letters "TUV" in bold, sans-serif font. The letters are stacked on top of each other, with the "T" on top and the "UV" below. The logo is enclosed in a rounded rectangle with multiple outlines. The logo appears to be a certification mark, possibly indicating that a product or service has been tested and certified by TUV.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) LTD P.O. Box 509 Edenvale 1610 Republic of South Africa
Re : K972319 Aurecast GF Trade Name: II Regulatory Class: Product Code: EJT Dated: June 13, 1997 Received: June 20, 1997
AUG 26 1997
Dear Mr. Davis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Davis
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
AURECAST GF evice Name:___________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Dental casting alloy for making restoration.
(NOT FOR USE WITH DENTAL PORCELAIN ) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUED ON OTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suoon Rumpr
(Division Sign-Off
and General Ho 5, 1 O(k) Numbe
Prescription Use " (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)